Context
A leading pharmaceutical company set out to establish a resilient global supply chain for Advanced Therapy Medicinal Products (ATMPs), with a specific focus on advancing its CAR-T program. This personalized medicine program relies on a seamless vein-to-vein process, where patient-specific materials are transported in cold chain solutions to cryopreservation centers, processed at manufacturing sites, and returned to patients as tailored treatments. Launching this initiative during the COVID-19 pandemic presented an opportunity to build a more agile and compliant supply chain capable of overcoming global logistics disruptions, complex regulatory requirements, and import/export challenges while ensuring uninterrupted patient care.
Ambition: building a resilient and compliant ATMP supply chain
Building a reliable ATMP supply chain presented a key opportunity to navigate diverse regulatory and trade compliance demands across regions while maintaining operational speed and precision. The COVID-19 pandemic further highlighted the need for flexible, resilient processes to manage logistics disruptions effectively. Delivering patient-specific therapies on time and in full regulatory compliance was critical to supporting the CAR-T program’s success and ensuring life-saving treatments reached patients without delay.
How we helped
We assisted in the design and implementation of a comprehensive ATMP operating model tailored to the client's needs. This included helping with the setup, further streamlining, and documentation of key processes to enhance efficiency and ensure compliance across regions. We provided support at operational, tactical, and strategic levels, mapping requirements, integrating courier systems, and implementing logistics processes to create a cohesive and agile supply chain infrastructure.
Results
The newly established processes empowered the client with a robust and efficient supply chain for the global delivery of ATMP therapies. Key improvements included an agile use of technology to integrate cold chain logistics with overall operations and effective stakeholder management. This strengthened the client’s capacity to manage disruptions, maintain regulatory adherence, and support the successful global rollout of the CAR-T program.
Ready to transform your ATMP logistics? Contact us today to learn how we can help you.
